NEW YORK, NY--(Marketwired - January 07, 2014) - LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of ZS Pharma (private), a biotechnology company developing ZS-9, an oral, selective potassium-binding treatment for patients with hyperkalemia. ZS Pharma recently announced positive results from a Phase 3 clinical trial and completed a successful Phase 2 trial demonstrating strong safety and efficacy of ZS-9 for the treatment of hyperkalemia. Both the Phase 2 and Phase 3 trials demonstrated a statistically significant decrease in serum potassium levels after 48 hours in patients receiving ZS-9. Additional data are expected from the Phase 3 trial on the safety and efficacy of ZS-9 after 12 days of treatment. A one-month maintenance trial is expected to launch in 2014 to support an NDA for ZS-9 as a treatment for hyperkalemia.
"Despite the clear link between hyperkalemia and mortality, the treatment options are limited, and there are currently no good therapies for patients with chronic hyperkalemia," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "ZS-9 is a unique product that has the right combination of selectivity, patient tolerability, and efficacy to potentially become the leading treatment for hyperkalemia."
Hyperkalemia is a disease of excess potassium in the blood typically caused by conditions that impact the filtration of potassium from the kidney, such as chronic kidney disease (CKD) and heart failure (HF). It has been linked to increased mortality and is associated with cardiac arrhythmias. Blood pressure medications such as ACE inhibitors exacerbate hyperkalemia by limiting potassium excretion, so to avoid elevated potassium levels patients are often under-treated for CKD and HF. An effective hyperkalemia therapy therefore has the potential to improve the management of associated diseases. ZS-9's mechanism of action supports hyperkalemia treatment regardless of the disease etiology. ZS-9 passes through the digestive tract, selectively binding and removing excess potassium, without the safety concerns of some existing products. The Phase 3 program is designed to support a broad label for ZS-9 and could significantly expand the market by reaching patients with chronic hyperkalemia, an indication with no FDA approved therapies.
In a 40 page Initiation Report by LifeSci Advisors, we explain the scientific support for ZS Pharma's clinical program and the Company's focus on developing the leading treatment for hyperkalemia. The report discusses the potential competitive advantages of ZS-9 over existing treatments and how these advantages position the drug in the marketplace. We highlight the large market potential and treatment gaps in hyperkalemia, including the lack of therapies for chronic hyperkalemia. The report critically examines competing products and development programs, and discusses the regulatory pathway towards approval for ZS-9.
Dr. McDonald's full Initiation Report is available to download at no cost at the LifeSci Advisors website, www.lifesciadvisors.com. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on the Company as developments occur.
The LifeSci Advisors research team is led by Dr. Andrew I. McDonald, an industry veteran with more than 15 years of healthcare industry experience. Prior to co-founding LSA, Dr. McDonald was the Senior Biotechnology Analyst at Great Point Partners, a leading health care investment firm with over $500 million under management. Before Great Point, he was Co-Head of Healthcare Research and Lead Biotechnology Analyst at ThinkEquity Partners, a boutique investment banking firm focused on growth companies. Dr. McDonald holds a Ph.D. in organic chemistry from the University of California, Irvine, and, earlier in his career, worked as a medicinal chemist at both Pfizer and Cytokinetics.
About LifeSci Advisors:
LifeSci Advisors (LSA) is a leading research firm and communications consultancy dedicated to the life sciences industry. The firm provides strategic counsel, customized marketing communications, comprehensive research reports and investor relations services to companies that specialize in the discovery, development and commercialization of drugs, drug delivery systems, medical devices and diagnostics. To learn more about LSA, visit the company's website, www.lifesciadvisors.com.
The research report described in this press release is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell securities. The securities discussed in LSA research reports may be unsuitable for some investors depending on their specific investment objectives, financial status, risk profile, or particular needs. Investors should consider LSA reports as only a single factor in making their investment decisions and should not rely solely on these reports in evaluating whether or not to buy or sell the securities of the subject company. LifeSci Advisors has been compensated by the company that is the subject of the report described and future research reports, investor relations services, and general consulting services. Please read each report's full disclosures and analyst background on the LSA website, www.lifesciadvisors.com, before investing. LifeSci Advisors is not a registered investment adviser or broker-dealer.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. These forward-looking statements represent LSA's judgment as of the date of this release. LifeSci Advisors disclaims, however, any intent or obligation to update these forward-looking statements.